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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05855785
Other study ID # 20-2020-38
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date April 8, 2021

Study information

Verified date May 2023
Source Seoul National University Boramae Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of the dual task exercise program on cognitive and physical function in the elderly with mild cognitive impairment.


Description:

All participants provided written informed consent before study participation. A total of 12 community-dwelling participants were randomized either to the exercise group or to the control group. The exercise group underwent 8-week, 3 times a week, 60-minute group exercise sessions, which were comprised of moderate-to-high intensity exercise and simultaneous cognitive tasks. They also performed moderate-intensity home aerobic exercises for at least 60 minutes per week. The control group performed 60-minute light intensity home exercise, 4 times a week for 8 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 8, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - a score on the Korean Montreal Cognitive Assessment (MoCA-K) of 25 points or below - aged 65 or more - no physical or medical problem which impairs moderate to vigorous physical activity Exclusion Criteria: - uncontrolled or unstable cardiovascular disease - malignancy affecting general condition - musculoskeletal problems affecting motor performance - speech and hearing impairment - other organic brain diseases

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
dual task exercise
8-week, 3 times a week, 60-minute group exercise sessions, which were comprised of moderate-to-high intensity exercise and simultaneous cognitive tasks
home exercise
60-minute light intensity home exercise, 4 times a week for 8 weeks

Locations

Country Name City State
Korea, Republic of Seoul National University Boramae Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Boramae Hospital National Rehabilitation Center, Ministry of Health and Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Plummer P, Eskes G. Measuring treatment effects on dual-task performance: a framework for research and clinical practice. Front Hum Neurosci. 2015 Apr 28;9:225. doi: 10.3389/fnhum.2015.00225. eCollection 2015. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dual task cost in Timed up and go (TUG) Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention.
For a ST condition, participants performed motor task only such as Timed up and go (TUG). TUG measured the time of taking to rise from a chair, walking three meters, turning around 180 degrees, walking back to the chair, and sitting down while turning 180 degrees. For a DT condition, participants performed TUG while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated TUG duration in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = [dual task duration or speed - single task duration or speed] / [single task duration or speed] * 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.
Baseline
Primary Dual task cost in 10-meter walking test Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention.
For a ST condition, participants performed motor task only such as 10-meter walking test (10MWT). 10MWT is a performance measure used to assess walking speed over a short distance. For a DT condition, participants performed 10MWT while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated 10MWT gait speed in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = [dual task duration or speed - single task duration or speed] / [single task duration or speed] * 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.
Baseline
Primary Dual task cost in Timed up and go (TUG) Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention.
For a ST condition, participants performed motor task only such as Timed up and go (TUG). TUG measured the time of taking to rise from a chair, walking three meters, turning around 180 degrees, walking back to the chair, and sitting down while turning 180 degrees. For a DT condition, participants performed TUG while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated TUG duration in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = [dual task duration or speed - single task duration or speed] / [single task duration or speed] * 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.
immediately after the 8-week intervention
Primary Dual task cost in 10-meter walking test Participants completed both single-task (ST) and dual-task (DT) tests at baseline and post-intervention.
For a ST condition, participants performed motor task only such as 10-meter walking test (10MWT). 10MWT is a performance measure used to assess walking speed over a short distance. For a DT condition, participants performed 10MWT while performing serial 3 simultaneously. Serial 3 is descending subtraction task, where the patient counts down from one hundred by threes. In the DT condition, participants were given no instruction regarding the prioritization of one task over the other. We calculated 10MWT gait speed in both conditions. Dual task cost(DTC) were calculated as a percentage as follows: (%DTC) = [dual task duration or speed - single task duration or speed] / [single task duration or speed] * 100%. The lower DTC indicates efficiency in cognitive-motor interplay and good dual task ability.
immediately after the 8-week intervention
Secondary Korean Montreal Cognitive Assessment (MoCA-K) MoCA-K is a screening test to assess cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, and calculation. MoCA-K is a test for mild cognitive impairment and it takes about 10 minutes to run. It assesses cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, calculation and support. Of a maximum 30 points, a score of 25 or higher is considered normal. Baseline
Secondary Korean Montreal Cognitive Assessment (MoCA-K) MoCA-K is a screening test to assess cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, and calculation. MoCA-K is a test for mild cognitive impairment and it takes about 10 minutes to run. It assesses cognitive functions such as attention, concentration, execution, memory, vocabulary, visual space, abstraction, calculation and support. Of a maximum 30 points, a score of 25 or higher is considered normal. immediately after the 8-week intervention
Secondary Korean Mini Mental Status Examination (K-MMSE) K-MMSE is a screening test for dementia that can evaluate various areas of cognitive function in a short time of 5 to 10 minutes such as time orientation, place orientation, memory, attention and calculation, understanding and judgment, and language. Of a maximum 30 points, a score of less than 24 is considered dementia. Baseline
Secondary Korean Mini Mental Status Examination (K-MMSE) K-MMSE is a screening test for dementia that can evaluate various areas of cognitive function in a short time of 5 to 10 minutes such as time orientation, place orientation, memory, attention and calculation, understanding and judgment, and language. Of a maximum 30 points, a score of less than 24 is considered dementia. immediately after the 8-week intervention
Secondary Computerized cognitive test(digit span test, visual learning test, verbal learning test, the Stroop Color and Word test, Boston naming test, trail making test, and verbal fluency test) Computerized cognitive test is a test method which quantitatively measures patients' cognitive problems in a systematic and standardized manner using a computer. Various neurocognitive function tests such as attention, memory, memory-motor coordination, and comprehensive cognitive thinking ability are possible through computerized cognitive test. Card sorting test, digit span test, visual learning test, verbal learning test, and Stroop word color test were conducted for precise cognitive function evaluation. Baseline
Secondary Computerized cognitive test(digit span test, visual learning test, verbal learning test, the Stroop Color and Word test, Boston naming test, trail making test, and verbal fluency test) Computerized cognitive test is a test method which quantitatively measures patients' cognitive problems in a systematic and standardized manner using a computer. Various neurocognitive function tests such as attention, memory, memory-motor coordination, and comprehensive cognitive thinking ability are possible through computerized cognitive test. Card sorting test, digit span test, visual learning test, verbal learning test, and Stroop word color test were conducted for precise cognitive function evaluation. immediately after the 8-week intervention
Secondary Short Physical Performance Battery (SPPB) SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people . The scores range from 0 (worst performance) to 12 (best performance). Baseline
Secondary Short Physical Performance Battery (SPPB) SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people . The scores range from 0 (worst performance) to 12 (best performance). immediately after the 8-week intervention
Secondary Berg Balance Scale (BBS) BBS is an evaluation tool designed to measure the balance of the elderly and consists of 56 points in 14 items that apply daily life movements. It is a measure to objectively evaluate static and dynamic balance ability in various postures such as sitting, standing, and posture change. Higher score means well balance function. Baseline
Secondary Berg Balance Scale (BBS) BBS is an evaluation tool designed to measure the balance of the elderly and consists of 56 points in 14 items that apply daily life movements. It is a measure to objectively evaluate static and dynamic balance ability in various postures such as sitting, standing, and posture change. Higher score means well balance function. immediately after the 8-week intervention
Secondary Falls Efficacy Scale (FES) FES is a questionnaire that evaluates the confidence to perform the activities without falling from the 10 activities. Higher score means good function. Baseline
Secondary Falls Efficacy Scale (FES) FES is a questionnaire that evaluates the confidence to perform the activities without falling from the 10 activities. Higher score means good function. immediately after the 8-week intervention
Secondary Activities-specific Balance Confidence (ABC) ABC consists of 16 surveys and it evaluates level of self-confidence in doing the activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0% to 100%. Baseline
Secondary Activities-specific Balance Confidence (ABC) ABC consists of 16 surveys and it evaluates level of self-confidence in doing the activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0% to 100%. immediately after the 8-week intervention
Secondary Grip strength Grip strength was measured by hand dynamometer for evaluating muscle strength. It is measured using pound(lb). Baseline
Secondary Grip strength Grip strength was measured by hand dynamometer for evaluating muscle strength. It is measured using pound(lb). immediately after the 8-week intervention
Secondary Korean version of Physical Activity Scale for the Elderly (K-PASE) K-PASE measures various physical activities of the elderly which are divided into sedentary life, leisure time activities, housework activities, and work-related activities. The score is calculated by multiplying the level and frequency of each activity using the conversion table. Higher score means higher activity. Baseline
Secondary Korean version of Physical Activity Scale for the Elderly (K-PASE) K-PASE measures various physical activities of the elderly which are divided into sedentary life, leisure time activities, housework activities, and work-related activities. The score is calculated by multiplying the level and frequency of each activity using the conversion table. Higher score means higher activity. during intervention(8 weeks)
Secondary International Physical Activity Questionnaires Short form (IPAQ) IPAQ Short form consists of 7 surveys and evaluate the degree of physical activity and the time spent on physical activity for one week. Baseline
Secondary International Physical Activity Questionnaires Short form (IPAQ) IPAQ Short form consists of 7 surveys and evaluate the degree of physical activity and the time spent on physical activity for one week. during intervention (8 weeks)
Secondary Metabolic Equivalent Task (MET) minutes per week MET minutes per week were evaluated to measure the degree of physical activity before intervention and every week during 8 weeks of intervention. MET minutes per week was calculated based on IPAQ. Baseline
Secondary Metabolic Equivalent Task (MET) minutes per week MET minutes per week were evaluated to measure the degree of physical activity before intervention and every week during 8 weeks of intervention. MET minutes per week was calculated based on IPAQ. during intervention(8 weeks)
Secondary Bioelectrical Impedance Analysis Bioelectrical Impedance Analysis was evaluated using Inbody for changes in body composition before and after intervention. Specifically, body weight, body fat percent, body mass index (BMI), skeletal muscle mass, lean mass, fat mass, waist hip ratio were evaluated. Baseline
Secondary Bioelectrical Impedance Analysis Bioelectrical Impedance Analysis was evaluated using Inbody for changes in body composition before and after intervention. Specifically, body weight, body fat percent, body mass index (BMI), skeletal muscle mass, lean mass, fat mass, waist hip ratio were evaluated. immediately after the 8-week intervention
Secondary Exercise Identity Scale (EIS) Exercise Identity Scale (EIS) is a measure of how important exercise is in daily life Baseline
Secondary Exercise Identity Scale (EIS) Exercise Identity Scale (EIS) is a measure of how important exercise is in daily life immediately after the 8-week intervention
Secondary Psychological Need Satisfaction in Exercise Scale (PNSE) Psychological Need Satisfaction in Exercise Scale (PNSE) is an exercise psychological measure consisting of detailed items of self-confidence, autonomy, and belonging related to exercise. Baseline
Secondary Psychological Need Satisfaction in Exercise Scale (PNSE) Psychological Need Satisfaction in Exercise Scale (PNSE) is an exercise psychological measure consisting of detailed items of self-confidence, autonomy, and belonging related to exercise. immediately after the 8-week intervention
Secondary Godin Leisure Time Exercise Questionnaire (GLTEQ) Godin Leisure Time Exercise Questionnaire (GLTEQ) is a self-report measure of the frequency of light-intensity, moderate-intensity, and vigorous-intensity leisure-time physical activity. It evaluated how satisfied the participants were with the intervention. Baseline
Secondary Godin Leisure Time Exercise Questionnaire (GLTEQ) Godin Leisure Time Exercise Questionnaire (GLTEQ) is a self-report measure of the frequency of light-intensity, moderate-intensity, and vigorous-intensity leisure-time physical activity. It evaluated how satisfied the participants were with the intervention. immediately after the 8-week intervention
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